BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER FEM HD 28/0MM T1

    MDR report key: 18612834 · Received January 31, 2024

    Report

    Report Number
    3002806535-2024-00036
    Event Type
    Injury
    Date Received
    January 31, 2024
    Date of Event
    April 27, 2023
    Report Date
    January 31, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271526
    PMA / PMN Number
    K200959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: G7 OSSEOTI 4 HOLE SHELL 54MM F; ITEM# 110010245; LOT# 7399538 G7 DUAL MOBILITY LINER 44MM F; ITEM# 110024464; LOT# 65723181 ACT ARTIC E1 HIP BRG 28X44MM; ITEM# EP-200150; LOT# 65723181 TPRLC 133 TYPE1 BM HO 12.0; ITEM# 51-114120; LOT# 3933746 G2 - FOREIGN: AUSTRALIA NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PRIMARY TOTAL HIP REPLACEMENT. SUBSEQUENTLY, THE PATIENT HAD A FALL AND FRACTURED THEIR FEMUR. THE PATIENT WAS REVISED TWENTY-ONE (21) DAYS POST INITIAL IMPLANTATION. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246696 DELTA CER FEM HD 28/0MM T1 HIP PROSTHESIS LZO BIOMET UK LTD. 3141276 00887868271526

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE H10 NARRATIVE